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Trial record 11 of 30 for:    cancer | First posted from 04/22/2016 to 04/22/2016

External Beam Radiotherapy for Muscle Invasive Bladder Cancer

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ClinicalTrials.gov Identifier: NCT02748200
Recruitment Status : Recruiting
First Posted : April 22, 2016
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
In this phase 1 trial, the investigators will prospectively evaluate 3 different external beam radiotherapy (EBRT) schedules. In every schedule, the whole bladder will be treated to 40 Gray (Gy) in 20 fractions, 5 fractions/week, 4 weeks in total. Based on the summation of abnormalities seen on pre- (initial tumor region) and post transurethral resection zone of fibrosis Diffusion weighted-magnetic resonance imaging (MRI) images the tumor region is delineated and defined as a gross tumor volume (GTV). The GTV will be treated using a simultaneous integrated boost (SIB): without extending the 4-weeks treatment period, 3 different dose levels will be implemented in order to increase the biological equivalent dose (BED), as muscle invasive bladder cancer has been shown to be dose-sensitive.

Condition or disease Intervention/treatment Phase
Toxicity Radiation: external beam radiotherapy (EBRT) Phase 1

Detailed Description:

3 different dose levels will be implemented in order to increase the biological equivalent dose (BED), as muscle invasive bladder cancer has been shown to be dose-sensitive.

  • Level 1: 57.6 Gray (Gy) (20 x 2.88 Gy, 5 fractions/week, 4 weeks); BED: 61 Gy.
  • Level 2: 60 Gy (20 x 3.00 Gy, 5 fractions/week, 4 weeks); BED: 64 Gy
  • Level 3: 62.4 Gy (20 x 3.12Gy, 5 fractions/week, 4 weeks); BED: 67 Gy. Fiducials will be implanted at the edges of the postoperative bed during the second transurethral resection of the bladder to improve visualization of the gross tumor volume (GTV) during external beam radiotherapy (EBRT) and consequently improve treatment delivery accuracy. In order to further improve the treatment accuracy, 5 planning Computed Tomographies and plans, with different bladder fillings will be made upfront in our study. During treatment the plan corresponding best with bladder filling at time of EBRT will be selected and delivered.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Muscle Invasive Bladder Cancer: External Beam Radiotherapy as an Alternative for Cystectomy
Study Start Date : March 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: external beam radiotherapy: Dose level 1
57.6 Gray (Gy) (20 x 2.88 Gy, 5 fractions/week, 4 weeks)
Radiation: external beam radiotherapy (EBRT)
EBRT: 3 dose escalation levels
Experimental: external beam radiotherapy: dose level 2
60 Gy (20 x 3.00 Gy, 5 fractions/week, 4 weeks)
Radiation: external beam radiotherapy (EBRT)
EBRT: 3 dose escalation levels
Experimental: external beam radiotherapy: dose level 3
62.4 Gy (20 x 3.12Gy, 5 fractions/week, 4 weeks)
Radiation: external beam radiotherapy (EBRT)
EBRT: 3 dose escalation levels


Outcome Measures

Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by Radiation Therapy Oncology Group toxicity scale [ Time Frame: 3 months after radiotherapy ]

Secondary Outcome Measures :
  1. Number of participants free from local relapse assessed on cystoscopy and Magnetic Resonance Imaging [ Time Frame: 12 months after radiotherapy ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histological proven diagnosis of muscle invasive bladder cancer
  • stage <T3b tumours with pathological lymph nodes after extended pelvic lymph node dissection
  • World Health Organisation performance state 0-2
  • signed informed consent

Exclusion Criteria:

  • contra-indication for Diffusion-Weighted-Magnetic resonance imaging
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748200


Contacts
Contact: Valérie Fonteyne, MD, PhD valerie.fonteyne@uzgent.be

Locations
Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Valérie Fonteyne, MD PhD       valerie.fonteyne@uzgent.be   
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Valérie Fonteyne, MD; PhD University Hospital, Ghent
More Information

Responsible Party: Radiotherapie, Radiation oncology and experimental cancer research, University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT02748200     History of Changes
Other Study ID Numbers: 2015/0169
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases